Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2020-11-09 to 2021-03-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2-(3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yloxy)ethyl acrylate and 2-(3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-6-yloxy)ethyl acrylate
Molecular formula:
C15 H20 O3
IUPAC Name:
Reaction mass of 2-(3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yloxy)ethyl acrylate and 2-(3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-6-yloxy)ethyl acrylate
Test material form:
liquid
Details on test material:
- Name: 2-Propenoic acid,2-[[3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5(or 6)-yl]oxy]ethyl ester
- CAS No.: 68169-12-0 (outside EU)
- EC Name: Reaction mass of 2-(3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yloxy)ethyl acrylate and 2-(3a,4,5,6,7,7ahexahydro-1H-4,7-methanoinden-6-yloxy)ethyl acrylate
- EC Number: 951-956-9
- Batch No.: OX8J0799
- Molecular Weight: 248.32 g/mol
- Physical State: liquid
- Colour: clear
- Active Components: 98.52% active components (different isomers), 1.48% 2-Cyclopenta-1,3-dienyloxyethan-1-ol
- Purity: 98.52%
- Expiry Date: 17 September 2023
- Storage Conditions: room temperature
- Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
At the start of the exposure and at the renewal (0 and 24 hours), samples were taken after preparation of the loading rates and analyzed. At the renewal and at the end of the exposure (24 and 48 hours), samples of the 24-hours old media were taken from the test vessels.

Test solutions

Details on test solutions:
Five water accommodated fractions (WAF) were prepared separately with nominal loading rates of the test item in the range of 0.512 to 12.0 mg/L set up in a geometric series with a factor of 2.2: 0.512 – 1.13 – 2.48 – 5.45 – 12.0 mg/L. For each loading rate, an appropriate amount of the test item was pipetted onto the surface of the dilution water in a glass bottle. For this purpose, the density was taken into account. These dispersions were shaken for 24 hours with 20 rpm at room temperature. After a separation phase of 1 hour, the aqueous phase or WAF was removed by siphoning (from the approximate centre of the glass flask). The WAFs were checked via laser beam (Tyndall effect) for undissolved test item (formation of an emulsion). No presence of undissolved test item during the test was observed. The resulting water accommodated fractions (WAF) were used in the test.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna STRAUS, obtained from continuous laboratory cultures.
The daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus. The algae were cultured at the test facility.
Less than 24 hours old daphnids from a healthy stock were used the start of the exposure for the study. To achieve this, juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period were used for the test. No first brood progeny was used for the test.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
247 - 251 mg CaCO3/L
Test temperature:
18 - 22 °C
pH:
7.57 - 8.46
Dissolved oxygen:
8.57 - 9.36 mg/L
Conductivity:
556 - 589
Nominal and measured concentrations:
Nominal loading rates (WAF): 0.512 – 1.13 – 2.48 – 5.45 – 12.0 mg/L
Details on test conditions:
The study was performed under semi-static conditions with a renewal of the test solutions after 24 hours.

Illumination (target): Diffuse light, light intensity of max. 1500 lx
Photoperiod (target): 16/8 hours light/dark cycle
Feeding: The daphnids were not fed during the study.
Reference substance (positive control):
yes

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
8.09 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks on result:
other: Water accommodated fractions (WAF)
Details on results:
Per definition of the WAF all terms related to concentration level were given as nominal loading rates because partly dissolved compounds and mixtures cannot be related to concentrations

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Based on the nominal loading rates, the 48 hours-EC50 for Daphnia magna was 8.09 mg/L (confidence limits: 5.45 to 12.0 mg/L) for the test item.
Executive summary:

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined at the test facility according to OECD 202.


The study was conducted under semi-static conditions over a period of 48 hours with five water accommodated fractions (WAF). The WAFs were prepared separately with nominal loading rates of the test item in the range of 0.512 to 12.0 mg/L set up in a geometric series with a factor of 2.2. Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each loading rate and the control.


The concentrations of the test item and the control were determined in fresh media (0 hours and 24 hours) and old media (24 hours and 48 hours) of all tested WAFs and the control via GC-MS.


Based on the nominal loading rates, the 48 hours-EC50 for Daphnia magna was 8.09 mg/L (confidence limits: 5.45 to 12.0 mg/L) for the test item.